Pre-loaded multiport delivery device

ABSTRACT

A pre-loaded stent graft delivery device and stent graft, the stent graft delivery device. The stent graft has at least one fenestration or side arm and the fenestration is preloaded with an indwelling guide wire. Indwelling access sheaths are provided within auxiliary lumens of a pusher catheter and dilators are preloaded into the access sheaths along with the indwelling guide wire. A handle assembly at a distal end of the guide wire catheter. The handle includes a multiport manifold with access ports to the auxiliary lumens in the pusher catheter. Upon deployment of the stent graft into the vasculature of a patient, the indwelling guide wire can be used to facilitate cathertisation of a side branch or target vessel through the fenestration or be used to stabilise the access sheath during catheterisation, advancement of the access sheath into the target vessel and deployment of a covered or uncovered stent therein through the access sheath.

RELATED APPLICATIONS

The present patent document is a continuation of application Ser. No.13/153,753, filed Jun. 6, 2011, which claims the benefit of priority toAustralian Patent Application No. 2010202487, filed Jun. 15, 2010, andentitled “Pre-Loaded Multiport Delivery Device,” the entire contents ofeach of which are incorporated herein by reference.

TECHNICAL FIELD

This invention relates to a medical device and more particularly to adevice for introduction or delivery of a stent graft into thevasculature of a patient.

SPECIFICATIONS REFERRED TO HEREIN

U.S. Pat. No. 7,435,253 entitled “Prosthesis and a Method of Deploying aProsthesis”

U.S. patent application Ser. No. 11/507,115, filed Aug. 18 2006 entitled“Assembly of Stent Grafts”

PCT/US09/03393 (Published WO 2009/148602 Dec. 10, 2009) entitled “TopCap Retrieval Arrangement”

U.S. patent application Ser. No. 11/904,834, filed Sep. 28, 2007entitled “Endovascular Delivery Device”

U.S. patent application Ser. No. 11/507,115, filed Aug. 18, 2006entitled “Assembly of Stent Grafts”

U.S. patent application Ser. No. 10/962,765, filed Oct. 12, 2004entitled “Fenestrated Stent Grafts”

U.S. patent application Ser. No. 11/706,114, filed Feb. 13, 2007entitled “Side Branch Stent Graft Construction”

BACKGROUND OF THE INVENTION

It is known to introduce endovascular stent grafts into the vasculatureof a patient to bridge an aneurism or damaged portion of the wall of thevasculature. Problems can occur, however, where the damage to thevasculature includes or is adjacent to a branch vessel from a mainartery because occlusion of the branch vessel may cause permanent damageto the patient.

Examples of such branch vessels are the renal and the mesentericarteries extending from the aorta.

Fenestrations in a stent graft have been proposed to allow access to thebranch vessel from a main stent graft but it is often necessary toprovide a side branch graft to maintain access into the branch vessel.Catheterisation of such a branch vessel from a delivery device throughthe fenestration enables deployment of a covered stent or uncoveredstent into the side vessel. This invention provides an improvedapparatus for catheterisation and deployment of side branch grafts.

Throughout this specification the term distal with respect to a portionof the aorta, a delivery device or a prosthesis means the end of theaorta, delivery device or prosthesis further away in the direction ofblood flow away from the heart and the term proximal means the portionof the aorta, delivery device or end of the prosthesis nearer to theheart. When applied to other vessels similar terms such as caudal andcranial should be understood.

Throughout this discussion the term “stent graft” is intended to mean adevice which has a tubular body of biocompatible graft material and atleast one stent fastened to the tubular body to define a lumen throughthe stent graft. The stent graft may be bifurcated and havefenestrations, side arms or the like. Other arrangements of stent graftsare also within the scope of the invention.2.

SUMMARY OF THE INVENTION

In one form the invention comprises a pre-loaded stent graft deliverydevice in combination with a stent graft, the stent graft deliverydevice comprising;

a guide wire catheter having a guide wire lumen therethrough;

a handle assembly at a distal end of the guide wire catheter, the handleincluding a multiport manifold; a nose cone dilator at the proximal endof the guide wire catheter, the nose cone dilator comprising a distalend and a distally facing capsule on the distal end of the nose conedilator; a pusher catheter extending from the manifold towards the anose cone dilator, the pusher catheter comprising a longitudinal pusherlumen therethrough and the guide wire catheter extending through thepusher lumen and the guide wire catheter able to move longitudinally androtationally with respect to the pusher catheter, the pusher cathetercomprising a proximal end spaced distally from the nose cone dilator andthereby defining between the proximal end of the pusher catheter and thenose cone dilator a stent graft retention region; the pusher cathetercomprising at least one longitudinal auxiliary lumen extending from themanifold to the proximal end of the pusher catheter; a sheath hub on thepusher catheter and a sheath arrangement extending from the sheath hubto the nose cone dilator, the sheath arrangement being coaxial with andsurrounding the guide wire catheter; the stent graft comprising atubular body of a biocompatible graft material, the tubular bodycomprising a peripheral wall and defining a lumen therethrough, aproximal end, a distal end, at least one fenestration in the peripheralwall and a proximally extending exposed self expanding stent; the stentgraft being received on the guide wire catheter in the stent graftretention region and within the sheath, the proximally extending exposedself expanding stent of the stent graft being releasably retained in thedistally facing capsule on the distal end of the nose cone dilator; anindwelling access sheath within the or each auxiliary lumen, theindwelling access sheath extending through the manifold from externalthereof and having a proximal end terminating distally of the stentgraft; an indwelling guide wire within the or each access sheath;

the indwelling guide wire extending proximally of the access sheaththrough the stent graft and exiting the at least one fenestration andextending proximally to the distally facing capsule;

whereby upon deployment of the stent graft into the vasculature of apatient the indwelling guide wire can be used to facilitatecathertisation of a side branch or target vessel or be used to stabilisethe access sheath during catheterisation, advancement of the accesssheath into the target vessel and deployment of a covered or uncoveredstent therein through the access sheath.

Preferably a dilator extends through the or each access sheath andcomprises a dilator tip at the proximal end of the or each accesssheaths, the dilator being able to be withdrawn through the accesssheath.

Preferably the manifold comprises at least one port and a haemostaticseal assembly in the or each port and the access sheath extendingthrough the haemostatic seal assembly. More preferably the manifoldcomprises two side ports and a through bore, the two side portsextending distally at an angle from the through bore, the pushercatheter comprising two auxiliary lumens and two side apertures at itsdistal end and the two side apertures opening respectively into the twoauxiliary lumens, the pusher catheter being received into the throughbore of the manifold such that the two side apertures open respectivelyinto the two side ports thereby providing a path for the accesscatheters.

Preferably pusher catheter comprises two longitudinal auxiliary lumensand the proximal end of the pusher catheter comprises an attachment bossand a scalloped end to provide exit ports for the auxiliary lumens.

Preferably the handle assembly comprises a proximal handle portion and adistal handle portion, the distal handle portion being movablelongitudinally with respect to the proximal handle portion, the guidewire catheter extending through each of the distal handle portion andthe proximal handle portion, the guide wire catheter being releasablyaffixed at a distal end to the distal handle portion, the nose conedilator and the distal handle portion being movable longitudinally withrespect to the proximal handle portion whereby the nose cone dilator canbe retracted independently of the manifold and pusher catheter.

Preferably the pre-loaded stent graft delivery device comprises a distalretrieval taper device in the distally facing capsule, the distalretrieval taper device being mounted onto the guide wire catheter andmovable longitudinally with respect to the guide wire catheter, a distalretrieval catheter coaxially on the guide wire catheter and movablelongitudinally with respect to the guide wire catheter, the distalretrieval catheter being fixed to the distal retrieval taper device at aproximal end and to the distal handle portion at a distal end, wherebymovement of the guide wire catheter in a proximal direction with respectto the distal handle portion moves the distally facing capsule withrespect to the distal retrieval taper device such that the distallyfacing capsule can move over the distal retrieval taper device to allowthe distal retrieval taper device to extend from the capsule whereby toprovide a smooth transition from the otherwise distal opening of thecapsule to enable retraction of the nose cone dilator through a deployedstent graft.

Preferably the proximal handle portion is releasably fastened to thedistal handle portion.

The stent graft can include diameter reducing ties and the deliverydevice further includes a release arrangement on the handle assembly forthe diameter reducing ties, the release arrangement for the diameterreducing ties comprising a first release grip on the handle and arelease wire extending from the first release grip to the diameterreducing ties.

There can be further included a retention arrangement for the distal endof the stent graft comprising a second release grip on the handleassembly and at least one trigger wire extending from the second releasegrip through the longitudinal pusher lumen and exiting the pusher lumenat the attachment boss and engaging the distal end of the stent graft.

The indwelling guide wire extending through the stent graft and exitingthe at least one fenestration and extending proximally within the mainsheath can comprise a releasable fastening whereby the indwelling guidewire is releasably fastened to the peripheral wall of the stent graftproximally of the fenestration to stabilise the indwelling guide wireduring advancement of the dilator and access sheath and catheterisationof the branch vessel. The releasable fastening of the indwelling guidewire can comprise a release wire stitched in to peripheral wall of thestent graft proximally of the fenestration, an engagement protrusion ofthe indwelling guide wire and a thread engaged around the release wireand the indwelling guide wire distally of the engagement protrusionwhereby upon retraction of the release wire the suture is released fromengagement with the indwelling guide wire.

It will be seen that by the various embodiments of the invention thereis provided a device where the pusher catheter and the sheaths for eachof the side branch catheterisation devices are included within the mainsheath of the stent graft with each of the components being able to bemanipulated separately. During deployment and before final placement ofthe covered or uncovered side branch stents the nose cone dilator can beretracted to distal of the fenestrations by movement of the distalhandle portion.

This then generally describes the invention but to assist withunderstanding reference will now be made the accompanying drawings whichshow preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a first embodiment of a pre-loaded stent graft deliverydevice according to the present invention;

FIG. 2 shows a longitudinal cross sectional view of the embodiment of astent graft delivery device of FIG. 1 according the present invention;

FIG. 2A shows the embodiment shown in FIG. 1 and in particular a detailof a part of the distal handle portion;

FIG. 2B shows the embodiment shown in FIG. 1 and in particular a detailof a part of the nose cone dilator and capsule with the distal retrievaltaper;

FIG. 3 shows the embodiment shown in FIG. 1 in a first partiallyactivated condition;

FIG. 4 shows the embodiment shown in FIG. 1 in a further partiallyactivated condition;

FIG. 5 shows the embodiment shown in FIG. 41 in longitudinal crosssection;

FIG. 5A shows the embodiment shown in FIG. 1 and in particular a detailof a part of the nose cone dilator and capsule with the distal retrievaltaper in its distal position;

FIG. 6 shows a perspective view of part of the handle of the embodimentshown in FIG. 1;

FIG. 7 shows the view of FIG. 6 in an activated condition;

FIG. 8 shows a transverse cross sectional view of the pusher catheterportion of the embodiment shown in FIG. 1 along the line 8-8′;

FIG. 9 shows an exploded view of a manifold of an embodiment of thepresent invention;

FIGS. 10A to 10D show various views of the pusher catheter of anembodiment of the present invention;

FIG. 11 shows a cross sectional view of the assembly of a manifold andpusher catheter according to the present invention;

FIG. 12 shows a schematic detailed side view of the stent graft retainedon the delivery device;

FIG. 13 shows a method of releasable retention of the indwelling guidewire,

FIGS. 14 and 15 show two embodiments of fenestrations suitable for thepresent invention, and

FIG. 16 shows an alternative embodiment of stent graft on a deliverydevice of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

The drawings, FIGS. 1 to 11D show a first embodiment of a pre-loadeddelivery device according to the present invention.

The delivery device 100 comprises a handle and manifold assembly 102 andintroduction portion 104 intended to be deployed into the patient by theknown Seldinger method. More specifically the introduction section 104includes a sheath 106 extending from a sheath hub 108 to a nose conedilator 110. A stent graft 131 is retained within the outer sheath 106in the region 107 just distal of the nose cone dilator 110.

The sheath hub and haemostatic seal 108 is positioned over a pushercatheter 112 which extends from and is connected into a manifold 114 asis discussed in more detail below. The manifold 114 has a proximal end114 b into which is affixed the pusher catheter 112 and two access ports116, 120 at its distal end 114 a. Access port 116 which has ahaemostatic seal 117 is for a first access sheath 118. Access port 120which has a haemostatic seal 121 is for a second access sheath 122. Atthe rear end 114 a of the manifold a handle assembly 130 is connected.The handle assembly 130 includes trigger wire release mechanisms and canbe separated into two parts is as discussed below.

The access sheath 118 extends to a haemostatic seal 132 through whichextends a dilator 134. On the dilator 134 is a dilator haemostatic seal136 through which extends an indwelling guide wire 138.

The access sheath 122 extends to a haemostatic seal 140 through whichextends a dilator 142. On the dilator 142 is a dilator haemostatic seal144 through which extends an indwelling guide wire 146.

The handle assembly 130 includes a proximal handle portion 124 which isaffixed to the rear of the manifold 114. The handle assembly 130 alsoincludes a distal handle portion 129. The distal handle portion 129 hasa proximal recess 129 a which fits over a distal extension 124 a of theproximal handle portion 124 and a locking screw 125 releasably locks thetwo handle portions together.

The distal handle portion 129 of the handle assembly 130 includestrigger wire release mechanisms releasably mounted onto it from itsdistal end as follows. Trigger wire release 160 is for the release ofthe stabilisation retention of indwelling guide wires as will bediscussed below. Trigger wire release 162 is for diameter reducing tiesas will be discussed below. Trigger wire release 164 is for a retentiontrigger wire for the exposed stent in the capsule as will be discussedbelow. Trigger wire release mechanism 166 is for the distal end of thegraft as will be discussed below. Trigger wire release mechanism 166 isalso part of the distal portion of the handle 129 and moves with it.

U.S. patent application Ser. No. 11/507,115, filed Aug. 18 2006 entitled“Assembly of Stent Grafts” teaches the use of diameter reducing ties forstent grafts and the teachings therein are incorporated herein in theirentirety.

A pin vice 170 is at the rear of the handle assembly 130 and the guidewire catheter 172 for the delivery device extends through the pin vice170 and is locked and can be released for movement with respect to thedistal portion of the handle 130 by the pin vice. The guide wirecatheter 172 terminates in a syringe point 174 to enable flushing liquidand radiopaque medium to be deployed through the delivery device.

The introduction portion 104 of the stent graft delivery device 100 hasthe nose cone dilator 110 and at the distal end of the nose cone dilator110 is a distally opening capsule 111 for the receipt of an exposedstent 137 of a stent graft 131. The capsule 111 has a slightly in-turneddistal end 117 (see FIGS. 4A and 5A). This has two purposes, a first isto assist with engagement of the sheath 106 of the delivery device whenthe nose cone dilator 110 is retracted into the sheath 106 and a secondis to prevent complete withdrawal of a distal retrieval taper device 113from the capsule as will be discussed below. The guide wire catheter 172passes through and is fastened to the nose cone dilator 110 at itsproximal end and passes through the handle assembly 130 of the deliverydevice. The pin vice arrangement 170 at the distal end of the distalhandle portion 129 locks movement of the guide wire catheter 172 withrespect to the distal portion of the handle 129 and can be loosened toallow relative motion between these components as discussed below.

The stent graft 131 shown in FIG. 2 for instance comprises a tubularbody of a biocompatible graft material such as Dacron, expanded PTFE orThoralon, a polyurethane material. The stent graft is supported by selfexpanding stents (not shown for clarity). A proximally extending exposedstent 137 assists with providing infra-renal fixation of the deployedstent graft. The stent graft has two fenestrations 147 which areprovided to give access to the renal arteries. The stent graft isretained on the delivery device by proximal retention of the exposedstent 137 into the capsule 111 of the delivery device and distally by atrigger wire retention 145 as will be discussed in detail below.Diameter reducing ties can be used to hold the stent graft in a diameterreduced condition during the initial catheterisation of a side branchbecause it may still be necessary to move the stent graft proximally ordistally or rotate it. In the diameter reduced condition this is stillpossible whereas when released to full diameter this may not bepossible.

U.S. Pat. No. 7,435,253 entitled “Prosthesis and a Method of Deploying aProsthesis” teaches arrangements for retaining a stent graft orprosthesis on a delivery or deployment device and allowing forindependent rotational and translational movement of each end of thestent graft and the teachings therein are incorporated herein in theirentirety.

As can be seen particularly in FIGS. 5 and 5A the distal retrieval taperdevice 113 fits coaxially around the guide wire catheter 172 and canmove longitudinally along the guide wire catheter. A retrieval catheter127 is mounted coaxially around the guide wire catheter 172 and can movelongitudinally along the guide wire catheter. At its proximal end theretrieval catheter 127 is joined to the distal retrieval taper device113 and at its distal end the retrieval catheter 127 is joined to thedistal handle portion 129 at 133 by a suitable adhesive 135. For thispurpose apertures are provided into the handle and adhesive is appliedthrough these apertures. FIG. 2A shows detail of the mounting of theretrieval catheter into the distal handle portion.

The distal retrieval taper device is shown in detail in FIGS. 5 and 5A.The distal retrieval taper device 113 has an enlarged shoulder 115 atits proximal end. The shoulder is sized so that it is of greaterdiameter than the smallest part of the in-turned distal end 117 of thecapsule 111. By this arrangement the distal retrieval taper device canmove through the capsule but cannot be fully removed from the capsule.The retrieval catheter 127 is coaxial with the guide wire catheter 172.At its proximal end the retrieval catheter 127 is affixed to the distalretrieval taper device and at its distal end the retrieval catheter 127is affixed to the distal handle portion 129 as shown in FIG. 2A. Thismeans that movement of the guide wire catheter 172 proximally withrespect to the distal handle portion 129, after release of the pin vice170 will move the nose cone dilator 110 and capsule 111 with respect tothe distal retrieval taper device with the effect that the distalretrieval taper extends from the capsule thereby providing a smoothtapered surface for retrieval of the nose cone dilator through the stentgraft. Locking of the pin vice after the distal retrieval taper 113 hasbeen moved to the distal end of the capsule 111 ensures that all of thedistal retrieval taper, the capsule, the nose cone dilator and thedistal handle portion all move together.

U.S. Provisional Patent Application Ser. No. 61/130,952, filed Jun. 4,2008 and entitled “Top Cap Retrieval Arrangement” teaches distalretrieval taper devices (referred to therein as tapered plugs) and theteaching therein is incorporated herein in its entirety.

By this arrangement the nose cone dilator can be moved to a distalposition with respect to fenestrations in the stent graft so that thenose cone dilator and distally opening capsule does not interfere withthe deployment of side branch covered or uncovered stent grafts throughsuch fenestrations nor does any subsequent retraction of the nose conedilator interfere with the deployed of side branch side branch coveredor uncovered stent grafts.

U.S. patent application Ser. No. 11/904,834, filed Sep. 28, 2007entitled “Endovascular Delivery Device” teaches apparatus and methods ofdeployment of stent grafts and side branch stent graft into fenestrationof such stent grafts and the teaching therein is incorporated herein inits entirety. The use of the stabilisation retention of the indwellingguide wire is particularly discussed therein.

As can be seen particularly in FIG. 8, which is a transverse crosssection along the line 8-8′ as shown in FIG. 1, the pusher catheter 112is surrounded by the sheath 106. The pusher catheter has threelongitudinally extending lumens. A first lumen is the guide wire lumen90 and this lumen is off-set from the centre of the pusher catheter toallow for two auxiliary lumens 92 and 94. The guide wire lumen 90 haspassing through it the guide wire catheter 172 and coaxially around thatthe retrieval catheter 127. Also in the guide wire lumen are the triggerwires for the diameter reducing ties 149, the top capsule 143, thedistal retention 141 and the auxiliary guide wire stabilisation 151. Theauxiliary lumen 94 has the access sheath 118 extending through it andthe dilator 134 and guide wire 138 extend through the access sheath 118.The auxiliary lumen 92 has the access sheath 122 extending through itand the dilator 142 and guide wire 146 extend through the access sheath122.

The manifold 114 and pusher catheter is shown in more detail in FIGS. 9to 11.

The manifold 114 has a through bore 200 and angled side ports 202 and204. The pusher catheter has three lumens as shown on FIG. 8, the guidewire lumen 90 and this lumen is off-set from the centre of the pushercatheter to allow for two auxiliary lumens 94 and 92. As can be seen inFIGS. 10A to 10 C the pusher catheter 112 has two side apertures 210 and212 which open from the side of the pusher catheter into the respectivelumens 92 and 94. These side apertures are elongate and tapered towardsthe distal end. When the pusher catheter is pushed into the through bore200 of the manifold 114 the side apertures in the pusher catheter alignwith the respective angled side ports 202 and 204 thereby providing anuninterrupted lumen from the access port 116 for the first access sheath118 into the pusher lumen 94 along the dotted line 203 and from accessport 120 for a second access sheath 122 into the pusher lumen 92 alongthe dotted line 205.

As can be best seen in FIG. 10A to 10D, at the proximal end of thepusher catheter is an attachment boss 220 and a scalloped end 222 toprovide exit ports for the two auxiliary lumens 92 and 94. The guidewire lumen 90 opens out at the proximal end of the attachment boss 220and to each side of the attachment boss there are apertures for triggerwires. Aperture 224 is for trigger wire 226 which is used for thediameter reducing ties on one side of the stent graft 131. Acorresponding aperture 228 and the other side of the attachment boss 220is for the trigger wire 230 for the other side of the stent graft 131.

Trigger wire 141 extends out of aperture 232 in the attachment boss 220and engages into the stent graft 131 before re-entering the attachmentboss at aperture 234 and exiting the guide wire lumen 90 at the proximalend of the pusher catheter 112.

Extending out of the two auxiliary lumens 92 and 94 are the auxiliarycatheters 122 and 118 respectively. From the proximal ends of therespective auxiliary catheters 118 and 122 extend dilators 134 and 142.The auxiliary guide wires 138 and 146 extend through the dilators.

FIG. 12 shows detail of the stent graft 131 and its retention system inthe region 107 as shown in FIG. 1. In particular there is detail shownof the distal attachment, the diameter reducing ties and the proximalretention.

The stent graft 131 is retained within the sheath 106 and concentricallyaround the guide wire catheter 172 and retrieval catheter 127. The stentgraft has a fenestration 147 towards its proximal end. In use the stentgraft is deployed so that the fenestration is substantially aligned witha renal artery and it is intended to catheterise the renal arterythrough the fenestration to deploy a covered or uncovered side branchstent or stent graft into the renal artery. The stent graft has aproximally extending exposed stent 137 at is proximal end 131 a. In itsready to deploy condition the proximally extending exposed stent 137 isreceived into the capsule 111 at the distal end of the nose cone dilator110. At its distal end 131 b the stent graft is retained to theattachment boss 220 at the proximal end of the pusher catheter 112.Trigger wire 141 engages the distal end of the stent graft. Trigger wire141 extends out of aperture 232 in the attachment boss 220 and engagesinto the stent graft 131 before re-entering the attachment boss throughaperture 234 into the guide wire lumen 90 and exiting the guide wirelumen 90 at the proximal end of the pusher catheter 112. At its distalend the trigger wire 141 is attached to the trigger wire releasemechanism 166. Trigger wire release mechanism 166 is also part of thedistal portion of the handle 129.

The stent graft 131 has diameter reducing tie arrangements to retain itin a partially diameter reduced condition even after the sheath 106 hasbeen retracted during deployment. The diameter reducing tie arrangementare on each side of the stent graft and comprise a trigger wire 160stitched along the graft material on either side of the stent graft andloops of filament such as suture thread 227 engaged around the triggerwire and a portion of the graft material part way around the stent graftand then drawn tight.

U.S. patent application Ser. No. 11/507,115, filed Aug. 18, 2006entitled “Assembly of Stent Grafts” teaches apparatus and methods ofdiameter reduction of stent grafts and the teaching therein isincorporated herein in its entirety.

FIG. 13 shows detail of the retention system 250 by which the guidewires 138 (for instance) is stabilised proximally of the fenestration147 (for instance). The guide wire 138 has a protrusion 252 which can befastened with respect to the guide wire by solder, crimping, welding orgluing. A suture thread 254 is looped 254 b around the guide wire 138distally of the protrusion 252 and around a release wire 256 which isstitched through the material of the stent graft 131 and then the suturethread 254 is sewn at 254 a into the material of the stent graft 131.When the release wire 256 is retracted the loop 254 b of the suturethread 254 is released and the guide wire 138 can be retracted. In themeantime the retention system stabilises the guide wire.

FIG. 14 shows a cross section of a simple fenestration in cross sectionwith the stabilised auxiliary guide wire extending through it. In thisembodiment the fenestration 260 is reinforced with a ring of resilientwire such as nitinol wire. The auxiliary guide wire 138 passes throughthe fenestration and is restrained just proximal of the fenestrationusing a retention system 250 as shown in FIG. 13.

U.S. patent application Ser. No. 10/962,765, filed Oct. 12, 2004entitled “Fenestrated Stent Grafts” teaches fenestrations in stentgrafts and the teaching therein is incorporated herein in its entirety.

FIG. 15 shows a cross section of an alternative fenestration arrangementincorporating a low profile side arm with the stabilised auxiliary guidewire extending through it. In this embodiment the fenestration 264 is inthe form of a low profile side arm 264. The low profile side arm 264 hasan inner portion 266 which extends within the tubular body of the stentgraft and an outer portion 268 which extends outside of the tubular bodyof the stent graft and is stitched into the periphery of thefenestration. The stitching extends circumferentially and diagonallyfrom one end of the low profile side arm to the other.

In FIG. 15 the fenestration is shown at the stage of deployment at whichthe first access sheath 118 has been advanced over the auxiliary guidewire 138 until it just extends out of the low profile side arm 264. Theauxiliary guide wire 138 passes through the fenestration and isrestrained just proximal of the fenestration using a retention system250 as shown in FIG. 13 and this stabilises the access sheath 118 whilecatheterisation of a side branch artery is occurring. The dilator hasbeen retracted and another guide wire 270 has been deployed through theaccess sheath 118 and this guide wire be used to catheterise of the sidebranch artery.

U.S. patent application Ser. No. 11/706,114, filed Feb. 13, 2007entitled “Side Branch Stent Graft Construction” teaches low profile sidearm fenestrations in stent grafts and the teaching therein isincorporated herein in its entirety.

FIG. 16 shows an alternative embodiment of stent graft on a deliverydevice of the present invention. In this embodiment the stent graft 270has two high flexibility side arms 272 and 274 which are intended forconnection to respective renal arteries, a fenestration 276 for theceliac artery and a scalloped proximal end 278 for the superiormesenteric artery. The auxiliary guide wires 138 and 146 extend from thepusher catheter 112 within the stent graft 270 and pass out through therespective two high flexibility side arms 274 and 272 and are thenstitched into the graft material to extend into capsule 111 on the nosecone dilator 110. The stitching into the stent graft material proximallyof the open ends of the two high flexibility side arms 272 and 274assists in stabilisation of the side arms during the catheterisation ofthe renal arteries.

In the embodiment of the delivery device shown in FIGS. 1 to 14 thefollowing components are present:

-   -   1/ Guide wire catheter 172 extending from a handle 130 to a nose        cone dilator 110.    -   2/ Handle 130 comprising a proximal handle portion 124 and a        distal handle portion 129. The handle has:        -   a) Trigger wire release for top cap 164,        -   b) Trigger wire release for diameter reducing ties 162        -   c) Trigger wire release for stabilisation retention of            indwelling guide wire 160 on the distal portion of handle            with respective trigger wires.        -   d) Trigger wire release for distal end of the stent graft on            distal handle portion with respective trigger wire 141.    -   5/ Pusher catheter 112 with lumens for access sheath 92, 94 and        guide wire catheter 90 joined to proximal handle portion 124 via        manifold 114.    -   6/ Sheath 106 with sheath hub 108 on pusher catheter 112.    -   7/ Nose cone dilator 110 with a distally opening top capsule        111.    -   8/ Indwelling guide wires 138, 146 through fenestrations 147 in        stent graft 131 and into top capsule 111. Indwelling guide wires        go through access sheaths 118, 122.    -   9/ Stabilisation retention system 250 of indwelling guide wires        138 and 146 proximally of fenestration 147.    -   10/ Distal retrieval taper 113 in top capsule 111 coaxial with        guide wire catheter 172 and a retrieval catheter 127 extending        from retrieval taper 113 to and fixed to distal portion of        handle 129.    -   11/ Access sheaths 118 and 122 having dilators 134 and 142        respectively within them and the dilators having dilator tips        135 and 143;    -   12/ Stent graft 131 with:        -   e) Proximally extending exposed stent 137 received in top            capsule 111 and a top cap trigger wire 143 retention        -   f) Distal retention at 145        -   g) Fenestrations for renal arteries, for instance 147        -   h) Radiopaque markers (not shown)        -   i) Diameter reducing ties 227 and trigger wire 160.

Introduction steps are as follows:

(a) Position the introduction part 104 of the delivery device 100 intothe aorta correctly taking into account N-S position as well asrotational position with respect to target vessels and fenestrations onthe stent graft 131 using markers on stent graft body. At this stage thedelivery device is as shown in FIGS. 1 and 2.

(b) Withdraw the outer sheath 106 of the delivery device whilecontinuing to check position until the distal end of the stent graftopens. At this stage the distal end of the stent graft is still retainedby distal fixation, the proximal end is retained by the exposed stentretained in top capsule of the delivery device and the expansion of thestent graft is restricted by the diameter reducing ties. This stage isshown in part in FIG. 3A.

(c) Advance the access sheaths 118, 122 (left and right) on theirrespective indwelling guide wires 138 146 through the lumen of stentgraft 131 to or through the fenestration 147 (at this stage the topcapsule still retains the exposed stent and the indwelling guide wires).

(d) Position the first access sheath at the opening of the fenestration.

(e) Remove the dilator 134 of the first access sheath.

(f) Advance an additional catheter and additional guide wire (4-5 Fr)through the first access sheath and into the target vessel (e.g. renalartery). The additional catheter may have a crooked or hockey stick tipto facilitate access.

(g) Remove the guide wire from the additional catheter and re-insert astiffer wire into the target vessel.

(h) Release the stabilisation retention system 250 of indwelling guidewires 138 via the trigger wire release 160.

(i) Retrieve the indwelling wire guide from the top cap and pull it outcompletely.

(j) Remove the additional catheter and replace the access sheath dilatorand dilator catheter over the stiffer wire in the target vessel andadvance the access sheath over the stiffer wire into the target vessel.Withdraw the access sheath dilator.

(k) Repeat steps (d) to (j) for the other of the target vessels.

(l) Advance covered stents through each of the access sheaths into thetarget vessels but do not release.

(m) Release the diameter reducing ties by releasing and withdrawingtrigger wire release 162.

(n) Release the top capsule 111 by removing the locking trigger wire 143via trigger wire release 164, releasing the pin vice 170 and advancingthe top capsule on the guide wire catheter and release the top exposedstent. At the same time the distally facing capsule moves proximallyover the distal retrieval taper device to allow the distal retrievaltaper device to extend from the distal end of the capsule. This stage isshown in FIG. 3.

(o) Tighten the pin vice 170.

(p) Retract the nose cone dilator, top cap and distal retrieval taperpast the fenestration by removing the locking screw 125 of the distalhandle portion and retracting distal portion of handle. This alsoreleases the distal attachment via trigger wire 141 connected to triggerwire release 166. This stage is shown in FIGS. 4, 5 and 7.

(q) One at a time, withdraw the access sheaths from the target vesselsand deploy covered stents between the fenestrations and target vesselsand balloon expand if necessary including flaring within the main stentgraft.

(r) Remove both access sheaths and also the guide wires from the targetvessels and withdraw them from the system.

(s) Retract the nose cone dilator, top cap and distal retrieval taper tothe sheath 106.

(t) Withdraw the entire assembly or leave the outer sheath in place forfurther deployments. Further deployment may include a bifurcated distalcomponent.

It is seen that by this invention an arrangement is provided that bywhich access sheaths may extend through the introduction device and areable to be separately manipulated to enable access to renal or otherarteries within the vasculature of a patient.

1. A stent graft delivery device having two indwelling access sheathspreloaded with a stent graft on the delivery device, the stent graftdelivery device comprising; a guide wire catheter having a guide wirelumen therethrough; a handle assembly at a distal end of the guide wirecatheter, the handle including a multiport manifold; a nose cone dilatorat the proximal end of the guide wire catheter; a pusher catheterextending from the manifold towards the nose cone dilator, the pushercatheter comprising a longitudinal pusher lumen therethrough and twolongitudinal auxiliary lumens, the pusher catheter completely enclosingthe two longitudinal auxiliary lumens radially, a sheath disposedcoaxially over the pusher catheter and the stent graft, the guide wirecatheter extending through the pusher lumen and the guide wire catheterable to move longitudinally and rotationally with respect to the pushercatheter, the pusher catheter comprising a proximal end spaced distallyfrom the nose cone dilator and thereby defining between the proximal endof the pusher catheter and the nose cone dilator a stent graft retentionregion; the stent graft comprising a stent structure, graft materialhaving a side wall, at least two fenestrations in the side wall of graftmaterial, a proximal end, a distal end and a lumen therethrough; themanifold comprising two side ports and a through bore, the two sideports extending distally at an angle from the through bore, the pushercatheter further comprising two apertures near the distal end of thepusher catheter and the two apertures opening respectively into the twoauxiliary lumens, the pusher catheter being in communication with thethrough bore of the manifold such that the two apertures communicaterespectively with the two side ports; an indwelling access sheath withineach auxiliary lumen, the indwelling access sheaths each configured toreceive a guide wire, the indwelling access sheaths extending throughrespective side ports, into the manifold from external thereof, into thedistal end of the stent graft, through the lumen of the stent graft, andout of respective fenestrations.
 2. The stent graft delivery device ofclaim 1, wherein each indwelling access sheath is configured to receivetherethrough a further delivery device comprising a side arm stent 3.The stent graft delivery device of claim 1, wherein each side port has ahaemostatic seal assembly and the respective access sheaths extendthrough the respective haemostatic seal assembly.
 4. The stent graftdelivery device of claim 1, wherein the stent graft has a scallop in theproximal end of the stent graft.
 5. The stent graft delivery device ofclaim 1, further comprising a distally facing capsule at a distal end ofthe nose cone dilator, wherein the proximal end of the stent graft isreleasably retained within the distally facing capsule.
 6. The stentgraft delivery device of claim 1, wherein the handle assembly comprisesa proximal handle portion and a distal handle portion, the distal handleportion being movable longitudinally with respect to the proximal handleportion, the guide wire catheter extending through each of the distalhandle portion and the proximal handle portion, the nose cone dilatorand the distal handle portion being movable longitudinally with respectto the proximal handle portion whereby the nose cone dilator can beretracted or advanced independently of the manifold and pusher catheter.7. The stent graft delivery device of claim 1, wherein the stent graftcomprises a self-expanding stent structure.
 8. The stent graft deliverydevice of claim 2, where the side arm stent is balloon expandable.
 9. Astent graft delivery device having two indwelling access sheathspreloaded with a stent graft on the delivery device, the stent graftdelivery device comprising; a guide wire catheter having a guide wirelumen therethrough; a handle assembly at a distal end of the guide wirecatheter, the handle including a multiport manifold; a nose cone dilatorat the proximal end of the guide wire catheter, the nose cone dilatorcomprising a distally facing capsule on the distal end of the nose conedilator; a pusher catheter extending from the manifold towards the nosecone dilator, the pusher catheter comprising a longitudinal pusher lumentherethrough and two longitudinal auxiliary lumens, the pusher cathetercompletely enclosing the two longitudinal auxiliary lumens radially, asheath disposed coaxially over the pusher catheter and the stent graft,the guide wire catheter extending through the pusher lumen and the guidewire catheter able to move longitudinally and rotationally with respectto the pusher catheter, the pusher catheter comprising a proximal endspaced distally from the nose cone dilator and thereby defining betweenthe proximal end of the pusher catheter and the nose cone dilator astent graft retention region; the stent graft comprising a stentstructure, graft material having a side wall, at least two fenestrationsin the side wall of the graft material, a proximal end releasablyretained within the distally facing capsule, a scallop in the proximalend of the graft, a distal end and a lumen therethrough; the manifoldcomprising two side ports and a through bore, the two side portsextending distally at an angle from the through bore, the pushercatheter further comprising two apertures near the distal end of thepusher catheter and the two apertures opening respectively into the twoauxiliary lumens, the pusher catheter being in communication with thethrough bore of the manifold such that the two apertures communicaterespectively with the two side ports; an indwelling access sheath withineach auxiliary lumen, the indwelling access sheaths each configured toreceive a guide wire, the indwelling access sheaths extending throughrespective side ports, into the manifold from external thereof, into thedistal end of the stent graft, through the lumen of the stent graft, andout of respective fenestrations.
 10. The stent graft delivery device ofclaim 1, wherein each indwelling access sheath is configured to receivetherethrough a further delivery device comprising a side arm stent 11.The stent graft delivery device of claim 1, wherein each side port has ahaemostatic seal assembly and the respective access sheaths extendthrough the respective haemostatic seal assembly.
 12. A method ofplacing a fenestrated stent graft in a body vessel at a treatment site,comprising: introducing a proximal end of a stent graft delivery deviceinto a body vessel and advancing the delivery device to the treatmentsite, the stent graft delivery device comprising; a guide wire catheterhaving a guide wire lumen therethrough; a handle assembly at a distalend of the guide wire catheter, the handle including a multiportmanifold; a nose cone dilator at the proximal end of the guide wirecatheter, the nose cone dilator comprising a distally facing capsule onthe distal end of the nose cone dilator; a pusher catheter extendingfrom the manifold towards the nose cone dilator, the pusher cathetercomprising a longitudinal pusher lumen therethrough and two longitudinalauxiliary lumens, the pusher catheter completely enclosing the twolongitudinal auxiliary lumens radially, a sheath disposed coaxially overthe pusher catheter and the stent graft, the guide wire catheterextending through the pusher lumen and the guide wire catheter able tomove longitudinally and rotationally with respect to the pushercatheter, the pusher catheter comprising a proximal end spaced distallyfrom the nose cone dilator and thereby defining between the proximal endof the pusher catheter and the nose cone dilator a stent graft retentionregion; the stent graft comprising a stent structure, graft materialhaving a side wall, at least two fenestrations in the side wall of thegraft material, a proximal end releasably retained within the distallyfacing capsule, a scallop in the proximal end of the graft, a distal endand a lumen therethrough; the manifold comprising two side ports and athrough bore, the two side ports extending distally at an angle from thethrough bore, the pusher catheter further comprising two apertures nearthe distal end of the pusher catheter and the two apertures openingrespectively into the two auxiliary lumens, the pusher catheter being incommunication with the through bore of the manifold such that the twoapertures communicate respectively with the two side ports; anindwelling access sheath within each auxiliary lumen, the indwellingaccess sheaths each configured to receive a guide wire, the indwellingaccess sheaths extending through respective side ports, into themanifold from external thereof, into the distal end of the stent graft,through the lumen of the stent graft, and out of respectivefenestrations; partially withdrawing the sheath from the stent graft toexpose the indwelling access sheaths; advancing a guide wire througheach of the access sheaths, out of the respective fenestration and intoa respective target branch vessel branching from the body vessel;advancing the at least one access sheath to the target branch vessel;releasing the proximal end of the stent graft from the distally facingcapsule; advancing a side arm stent through each of the indwellingaccess sheaths and at least partially out of the respective fenestrationand into the respective target branch vessel, the side arm stents eachhaving a proximal end and a distal end; expanding each of the side armswithin the target vessel with a balloon; flaring the proximal ends ofthe side arm stents within the lumen of the stent graft.